FDA.reportPublic FDA data

Traufix osteosynthesis, osteotomy, and arthrodesis devices

Primary DI
07506494217038
Brand
Traufix osteosynthesis, osteotomy, and arthrodesis devices
Company
Fixier, S.A. de C.V.
Model
171.46
Catalog number
171.46
Device description
5.0mm titanium cannulated cortex locking screw 46mm
Published
2022-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201510000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201510000Traufix osteosynthesis, osteotomy, and arthrodesis devicesFixier S.A. DE C.V.2022-02-18HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07506494217038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07506494217038075064942170387506494217038

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, non-sterileA small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+524196881191internationalsales@fixier.com.mx

Regulatory Flags#

DUNS number
951561048
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07506494214792Traufix osteosynthesis, osteotomy, and arthrodesis devices150.04150.042022-09-21
07506494214808Traufix osteosynthesis, osteotomy, and arthrodesis devices150.06150.062022-09-21
07506494214815Traufix osteosynthesis, osteotomy, and arthrodesis devices150.08150.082022-09-21
07506494214822Traufix osteosynthesis, osteotomy, and arthrodesis devices150.10150.102022-09-21
07506494214839Traufix osteosynthesis, osteotomy, and arthrodesis devices150.12150.122022-09-21
07506494214846Traufix osteosynthesis, osteotomy, and arthrodesis devices150.14150.142022-09-21
07506494214853Traufix osteosynthesis, osteotomy, and arthrodesis devices151.04151.042022-09-21
07506494214860Traufix osteosynthesis, osteotomy, and arthrodesis devices151.06151.062022-09-21
07506494214877Traufix osteosynthesis, osteotomy, and arthrodesis devices151.08151.082022-09-21
07506494214884Traufix osteosynthesis, osteotomy, and arthrodesis devices151.10151.102022-09-21
07506494214891Traufix osteosynthesis, osteotomy, and arthrodesis devices151.12151.122022-09-21
07506494214907Traufix osteosynthesis, osteotomy, and arthrodesis devices151.14151.142022-09-21
07506494214914Traufix osteosynthesis, osteotomy, and arthrodesis devices152.04152.042022-09-21
07506494214921Traufix osteosynthesis, osteotomy, and arthrodesis devices152.06152.062022-09-21
07506494214938Traufix osteosynthesis, osteotomy, and arthrodesis devices152.08152.082022-09-21
07506494214945Traufix osteosynthesis, osteotomy, and arthrodesis devices152.10152.102022-09-21
07506494214952Traufix osteosynthesis, osteotomy, and arthrodesis devices152.12152.122022-09-21
07506494214969Traufix osteosynthesis, osteotomy, and arthrodesis devices152.14152.142022-09-21
07506494214976Traufix osteosynthesis, osteotomy, and arthrodesis devices153.04153.042022-09-21
07506494214983Traufix osteosynthesis, osteotomy, and arthrodesis devices153.06153.062022-09-21

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Primary DI, Brand, Company table
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00842188131677CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00842188131721CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00889095401820ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401844ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
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